(22 days)
Resume II Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.
SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.
Quadripolar implantable neurostimulation surgical leads with in-line connector.
The provided document is a 510(k) summary for Medtronic In-Line Surgical Leads for Neurostimulation. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a clinical study for a novel device might.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy, or clinical outcomes) and then present corresponding device performance values against these criteria. Instead, it asserts substantial equivalence based on technological characteristics and indications for use matching predicate devices, and the results of "testing" which are not detailed.
Therefore, a table of acceptance criteria and reported device performance as typically expected for clinical efficacy/safety outcomes cannot be constructed from this document. The "criteria for acceptance" implicitly are that the technological characteristics and indications for use of the new devices are similar to the predicate devices, and that testing (which is not described in detail) supports their safety and effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states "Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification," but the details of this data (including sample size, study design, or provenance) are not included in the summary. This appears to be a bench testing type of performance data and does not indicate human clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The document describes a comparison to predicate devices and general performance testing, not a study involving expert assessment of ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The assessment described is not a clinical study requiring adjudication of ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This document describes medical device leads, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study related to human readers improving with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes medical device leads, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided. The document focuses on demonstrating substantial equivalence through technological characteristics and general performance testing, not on validating accuracy against a clinical ground truth.
8. The sample size for the training set
This information is not applicable/not provided. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This document does not describe a machine learning algorithm or a training set.
Summary of what the document does convey regarding "acceptance criteria" and "study":
The "study" described is primarily a substantial equivalence comparison to predicate devices. The implicit "acceptance criteria" for regulatory clearance are that the proposed devices (Medtronic In-Line Surgical Leads) are substantially equivalent to the predicate devices (Resume II 3587A, Resume TL 3986, SymMix 3982, On-Point 3987A) in terms of:
- Technological characteristics: The document states, "The technological characteristics of the proposed ILS leads for neurostimulation are substantially equivalent to the noted predicate devices."
- Indications for Use: The indications for use for the new devices are explicitly listed and are identical or highly similar to those of the predicate devices.
- Performance Data: The document states that "Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification." This performance data is not detailed in the summary, but it would typically consist of bench testing (e.g., mechanical strength, electrical properties, biocompatibility) to ensure the device meets engineering specifications and functions as intended, providing evidence for safety and effectiveness similar to the predicate devices. There is no indication of human clinical study data being used for this 510(k) submission.
In essence, the "study" is a substantiation of equivalence rather than a clinical trial demonstrating efficacy against pre-defined performance metrics.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).